Cl II Zimmer Biomet Orthosize Templating

Company: Zimmer Biomet, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Recall Number Z-1495-2017

REASON
Digital templates were created with the incorrect files.

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc., Warsaw, IN on 2/14/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3232

DISTRIBUTION
Nationwide and Internationally

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